RecruitingEarly Phase 1NCT06220214

Neoadjuvant Therapy and Contrast-enhanced Mammography for Early Stage Breast Cancer

Contrast Enhanced Digital Mammography for Predicting Pathologic Complete Response After Neoadjuvant Chemotherapy


Sponsor

Alison Stopeck

Enrollment

30 participants

Start Date

Mar 6, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to compare a special type of mammogram that uses a contrast agent called contrast-enhanced digital mammography with contrast-enhanced digital breast tomosynthesis (CEDM+CEDBT), with breast magnetic resonance imaging imaging (MRI) for predicting the effect of neoadjuvant chemotherapy on pathologic complete response rates. The device used to obtain CEDM+CEDBT images is called Siemens MAMMOMAT. This device produces two-dimensional (2D) images, as in a normal mammogram, but also collects additional images for digital breast tomosynthesis (DBT), which produces a three-dimensional (3D) image of the breast in the form of image slices. DBT allows the radiologist to "see through" the breast tissue for better detection and localization of breast cancer. By looking at both the CEDM images and the CEDBT images, a radiologist may be able to better detect residual breast cancer in a more cost-effective manner. Participation may last up to 18 weeks. Study procedures for this research are: * Undergoing 1-2 mammograms during and/or after your chemotherapy, but before primary breast surgery. * Before each mammogram, have a radiology technician inject a liquid contrast agent by inserting a needle into a vein. The chemotherapy port cannot be used to receive the contrast agent * Let the research team record information from your medical record related to your condition and the treatment you receive. * Give permission to collect leftover tissue from your diagnostic biopsy and breast surgery.


Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria2

  • Diagnosis with either type of invasive locally advanced breast cancer regardless of hormone receptor or Her2 status
  • Plan to receive at least 4 cycles of neoadjuvant chemotherapy ahead of definitive surgery

Exclusion Criteria4

  • Pregnancy
  • Allergy/sensitivity to contrast agent
  • Decreased kidney function
  • Diabetes

Interventions

DIAGNOSTIC_TESTCEDM

Contrast Enhanced Digital Mammography

DIAGNOSTIC_TESTCEDBT

Contrast-Enhanced Digital Breast Tomosynthesis

DRUGOmnipaque 350mgI/mL Solution for Injection

Injection of an FDA approved iodinated contrast agent is required to undergo the imaging procedures. It is not the intent of the study to evaluate the contrast agent, but it will be administered at the time of experimental imaging.


Locations(1)

Stony Brook Breast Center

Stony Brook, New York, United States

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NCT06220214


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